RU2683823C2 - Препарат гормона роста человека длительного типа - Google Patents

Препарат гормона роста человека длительного типа Download PDF

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Publication number
RU2683823C2
RU2683823C2 RU2016113684A RU2016113684A RU2683823C2 RU 2683823 C2 RU2683823 C2 RU 2683823C2 RU 2016113684 A RU2016113684 A RU 2016113684A RU 2016113684 A RU2016113684 A RU 2016113684A RU 2683823 C2 RU2683823 C2 RU 2683823C2
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Russia
Prior art keywords
long
growth hormone
human growth
acting
conjugate
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RU2016113684A
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English (en)
Russian (ru)
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RU2016113684A (ru
RU2016113684A3 (es
Inventor
Хва Поунг РИМ
Хьюн Ок Ким
Хо Тэк ИМ
Сан Юн Ким
Хьюнг Кю Лим
Сан Мин Бэ
Се Чан КВОН
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Ханми Фарм. Ко., Лтд.
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Publication of RU2016113684A3 publication Critical patent/RU2016113684A3/ru
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/27Growth hormone [GH] (Somatotropin)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6883Polymer-drug antibody conjugates, e.g. mitomycin-dextran-Ab; DNA-polylysine-antibody complex or conjugate used for therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/10Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
RU2016113684A 2013-09-27 2014-09-26 Препарат гормона роста человека длительного типа RU2683823C2 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR20130115177 2013-09-27
KR10-2013-0115177 2013-09-27
PCT/KR2014/009059 WO2015046974A1 (ko) 2013-09-27 2014-09-26 지속형 인간 성장 호르몬 제제

Publications (3)

Publication Number Publication Date
RU2016113684A RU2016113684A (ru) 2017-11-01
RU2016113684A3 RU2016113684A3 (es) 2018-06-28
RU2683823C2 true RU2683823C2 (ru) 2019-04-02

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RU2016113684A RU2683823C2 (ru) 2013-09-27 2014-09-26 Препарат гормона роста человека длительного типа

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US (2) US10987425B2 (es)
EP (2) EP3050559B1 (es)
JP (1) JP6549104B2 (es)
KR (1) KR102276304B1 (es)
CN (2) CN105848645A (es)
AR (1) AR097840A1 (es)
AU (1) AU2014329003A1 (es)
BR (1) BR112016006455A2 (es)
CA (1) CA2925416A1 (es)
HK (1) HK1225976A1 (es)
IL (1) IL244769A0 (es)
MX (1) MX2016003705A (es)
RU (1) RU2683823C2 (es)
TW (1) TW201605468A (es)
WO (1) WO2015046974A1 (es)

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KR20130049671A (ko) 2011-11-04 2013-05-14 한미사이언스 주식회사 생리활성 폴리펩타이드 결합체 제조 방법
AR090281A1 (es) 2012-03-08 2014-10-29 Hanmi Science Co Ltd Proceso mejorado para la preparacion de un complejo polipeptidico fisiologicamente activo
SG10202107752PA (en) * 2014-03-31 2021-09-29 Hanmi Pharmaceutical Co Ltd Method for improving solubility of protein and peptide by using immunoglobulin fc fragment linkage
KR101808234B1 (ko) 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
KR20170079409A (ko) * 2015-12-30 2017-07-10 한미약품 주식회사 지속형 인간 성장 호르몬 결합체의 신규 액상 제제
CN106256835A (zh) * 2016-08-19 2016-12-28 安源医药科技(上海)有限公司 高糖基化人生长激素融合蛋白及其制备方法与用途
KR101861163B1 (ko) 2017-04-26 2018-05-25 삼천당제약주식회사 안과용 약학 조성물
IL298396A (en) * 2020-05-22 2023-01-01 Hanmi Pharm Ind Co Ltd A liquid formulation of a long-acting conjugate of a glucagon derivative
CN115845032A (zh) * 2022-10-28 2023-03-28 深圳科兴药业有限公司 生长激素fc融合蛋白注射液及其用途

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WO1993019776A1 (en) * 1992-04-03 1993-10-14 Kabi Pharmacia Ab Protein formulation comprising growth hormone
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RU2229288C2 (ru) * 1995-07-27 2004-05-27 Джинентех, Инк. Стабильная изотоническая лиофилизированная протеиновая композиция
RU2436796C2 (ru) * 2006-05-30 2011-12-20 Дженентек, Инк. Антитела и иммуноконъюгаты и их применения
WO2012008779A2 (en) * 2010-07-14 2012-01-19 Hanmi Holdings Co., Ltd. A liquid formulation of long-acting human growth hormone conjugate

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Publication number Priority date Publication date Assignee Title
WO1993019776A1 (en) * 1992-04-03 1993-10-14 Kabi Pharmacia Ab Protein formulation comprising growth hormone
RU2229288C2 (ru) * 1995-07-27 2004-05-27 Джинентех, Инк. Стабильная изотоническая лиофилизированная протеиновая композиция
RU2191029C2 (ru) * 1996-02-12 2002-10-20 Си Эс Эл ЛИМИТЕД Композиция стабилизированного гормона роста и способ ее приготовления
RU2436796C2 (ru) * 2006-05-30 2011-12-20 Дженентек, Инк. Антитела и иммуноконъюгаты и их применения
WO2012008779A2 (en) * 2010-07-14 2012-01-19 Hanmi Holdings Co., Ltd. A liquid formulation of long-acting human growth hormone conjugate

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Publication number Publication date
IL244769A0 (en) 2016-04-21
JP6549104B2 (ja) 2019-07-24
EP3050559B1 (en) 2020-06-03
KR20150035681A (ko) 2015-04-07
AR097840A1 (es) 2016-04-20
RU2016113684A (ru) 2017-11-01
AU2014329003A1 (en) 2016-05-12
US10987425B2 (en) 2021-04-27
EP3689335A1 (en) 2020-08-05
CN114288254A (zh) 2022-04-08
EP3050559A4 (en) 2017-05-31
US20160213789A1 (en) 2016-07-28
KR102276304B1 (ko) 2021-07-14
RU2016113684A3 (es) 2018-06-28
TW201605468A (zh) 2016-02-16
CN105848645A (zh) 2016-08-10
CA2925416A1 (en) 2015-04-02
US20210138070A1 (en) 2021-05-13
EP3050559A1 (en) 2016-08-03
HK1225976A1 (zh) 2017-09-22
JP2016533345A (ja) 2016-10-27
WO2015046974A1 (ko) 2015-04-02
MX2016003705A (es) 2016-05-16
BR112016006455A2 (pt) 2017-08-01

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Effective date: 20200927